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Renvela

Sevelamer Carbonate · Powder, for Suspension

Prescription NDA TE AB RLD

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name

Renvela

Generic name

Sevelamer Carbonate

Dosage form

Powder, for Suspension

Route

Oral

Marketing category

NDA · NDA

Labeler

Genzyme Corporation

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

54% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Sevelamer Carbonate	2400 mg/1	749206	View
Sevelamer Carbonate	800 mg/1	749206	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Powder, for Suspension

Route of administration

Oral

Presentations

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Phosphate Binder [EPC]	EPC	All 42 members
Phosphate Chelating Activity [MoA]	MoA	All 42 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

022318

Application type

NDA · New Drug Application

Approval date

August 12, 2009

Sponsor

GENZYME

Products on application

Submissions recorded

Products approved under application 022318.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
022318-001	RENVELA	FOR SUSPENSION		SEVELAMER CARBONATE	Discontinued	AB	RLD
022318-002	RENVELA	FOR SUSPENSION		SEVELAMER CARBONATE	Discontinued	AB	RLD

Therapeutic equivalence

Source: Orange Book

TE code

Reference Listed Drug

Yes

Reference Standard

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book

Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent	Expires	Product	Substance	Use code	Submitted
9095509	December 6, 2030	001	No		January 13, 2016
9095509	December 6, 2030	002	No		January 13, 2016

Approval history

Source: Drugs@FDA

Most recent submissions on application 022318.
Type	No.	Action	Status	Date	Review
Supplement	12	Labeling	Approved	April 30, 2020	Standard
Supplement	8	Efficacy	Approved	November 25, 2016	Priority
Supplement	6	Labeling	Approved	March 9, 2016	Standard
Supplement	5	Labeling	Approved	November 26, 2014	Standard
Supplement	3	Labeling	Approved	June 16, 2011	Unknown
Original application	1	Type 3 - New Dosage Form	Approved	August 12, 2009	Standard

Review documents

0 · Supplement · May 4, 2020
0 · Supplement · May 1, 2020
0 · Supplement · December 1, 2016
0 · Supplement · November 28, 2016
0 · Supplement · March 14, 2016
0 · Supplement · March 11, 2016
0 · Supplement · December 17, 2014
0 · Supplement · November 28, 2014
0 · Supplement · June 24, 2011
0 · Supplement · June 16, 2011
0 · Original application · February 3, 2011
0 · Original application · February 3, 2011
0 · Original application · October 1, 2009
0 · Original application · August 17, 2009

Adverse event reports

Source: openFDA FAERS

11,427

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: SEVELAMER CARBONATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
58468-0131-2	58468-0131	Genzyme Corporation	90 PACKET in 1 CARTON (58468-0131-2) / 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0131-1)	August 12, 2009
58468-0132-2	58468-0132	Genzyme Corporation	90 PACKET in 1 CARTON (58468-0132-2) / 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0132-1)	August 12, 2009
58468-0131	58468-0131	Genzyme Corporation	—	August 12, 2009
58468-0132	58468-0132	Genzyme Corporation	—	August 12, 2009

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Orange Book	FDA	Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.